Marc Hogreve has been working for Sartorius since 2006. After graduating in engineering, he took care of the development of lab equipment like shakers, incubation shakers and homogenisers. As of 2011, he has been working as a senior scientist for integrity testing solutions with a focus on single-use sys­tems for fluid management. As a special matter expert in that area he is part of several task forces writing standards and best practices for the container closure integrity of single-use systems.

Dr. Olivier Chancel is a doctoral pharmacist, graduating in technological pharmacy, quality control, and management. He is currently a sterility and aseptic practice assurance expert and formerly head of performance and pharmaceuticals in Merial, Toulouse, France. He provides corporate support for sterility and aseptic processes to Merial sites. He used to work in the pharmaceutical industry for 15 years in various positions including pharma­ceutical research and development, quality assurance, quality control, proj­ect management, and production for both solid and injectable dosage forms. He has published a number of papers in peer-reviewed journals relating to cleanroom activities or aseptic practices and also presented/moderated vari­ous industry forums in Europe and the US (PDA, A3P, SFSTP, SMI, ASPEC, ECA, PHARMIG).

Matthias Angelmaier has a bachelor’s degree in industrial and mechanical en­gineering as well as a master’s degree in business development. He joined Robert Bosch GmbH in 2009. During his first three years, he was a project manager for handling complex customer projects. Since 2012, he has been the globally responsible product manager for barrier systems and isolator technology. His expertise includes process engineering, sterilisation, bio decontamination and glove testing systems.

Thomas Schwarz has a PhD in chemistry and an executive MBA. He joined Aventis in 1999 in Frankfurt, where he worked in recombinant insulin pro­duction. He has worked at Novartis since 2006 in a variety of functions in­cluding process manager of sterile manufacturing, plant manager of biotech in the US and QA/QV team leader. He is currently the head of strategic plan­ning for aseptics, which includes nine drug product sites around the globe.

Brian G. Hubka is the CEO of Contamination Prevention Technologies, Inc. This company provides a vast array of contamination remediation and prevention technologies and products to eliminate and prevent mould, bacteria, viruses, prions and the like. They are also specialists in biofilm remediation and elimination. Additionally, he consults on contamination issues in pharmaceutical and biotechnology companies.

Brian is a graduate of the University of Notre Dame. He is also a frequent speaker and has authored book chapters for many PDA/DHI books.

Jeanne Moldenhauer, vice president of Excellent Pharma Consulting, has more than 30 years’ experience in the pharmaceutical industry. She chaired the Environmental Monitoring/Microbiology Interest Group of PDA for more than 15 years, served on the Scientific Advisory Board of PDA for 20 years, founded the Rapid Microbiology User’s Group™ and is a member of ASQ and RAPS. She is the author of many books and numerous publications including book chapters and magazine articles.

Walid El Azab is an industrial pharmacist, a qualified person and a Lean Six Sigma green belt. He is a technical services manager for STERIS Life Sciences. He provides technical support related to cleaning, disinfectants, sterility assurance and process validation. Finally, he leads audits at manu­facturer sites and workshops to improve processes and inspection readiness level. Walid is a lecturer at a pharmacy and medicine university. He has published different articles and book chapters, and he is also part of working groups on sterilisation and EU GMP Annex 1 guideline revision. He is a plan­ning committee member of the Annual PDA Conference on Pharmaceutical Microbiology (12th and 13th editions), and part of the editorial committee of the PDA Letter. Walid is an observer member of the ISPE Belgium affiliate board. Finally, he is secretary of the Belgium Qualified Person Association.

Elizabeth (Lisa) Dorn has been in the pharma industry for over 30 years, guiding clients on innovative aseptic filling facility design and operations. As a recognised industry expert, she frequently assists clients with regulatory reviews, facility design, equipment selection, startup and operations. Lisa has a global understanding of aseptic filling facilities, having delivered projects in Korea, Japan, Canada, Scotland, Russia, Switzerland and the United States. She is a current member of the Parenteral Drug Association, International Society for Pharmaceutical Engineering and American Institute of Chemical Engineers, and she is invited to present at industry events across the United States.

Lise Vanderkelen received her Ph.D. from the Faculty of Bioscience Engineering at the Universi­ty of Leuven (Belgium) in 2012. She started at Nelson Labs Europe (formerly Toxikon Europe) in 2013 as study director at the Extractables & Leachables Department, focusing on Injectables and Parenterals and in 2014 she became responsible for the chemical characterization testing for the medical device industry. In 2016, she became Department Head Pharma Services at Nelson Labs Europe. The main focus of this department is identifying organic impurities in drug products as well as in use stability of drug-device combination. In 2017, the scope expanded and includes now also all microbiological testing offered at Nelson Labs Europe.

David Estapé holds a PhD degree in chemical engineering from the University of Barcelona, Spain. He has over 20 years of international experience in facility design and GMP consulting within the biotech, vaccine and blood plasma pharmaceutical sectors for startups to lead pharmaceutical companies. He is passionate about collaborating in industry forums like ISPE and BPOG to share and win overall manufacturing and engineering expertise, especially on new technology trends and regulatory requirements, to enhance facility design and engineering.

Annick Gillet has a biochemistry background and began her career at Sterigenics about 10 years ago as quality manager for the Belgian plant, managing the quality system, the QC team and the validation team. She acted as the main contact during customer and regulatory inspections (FDA, European Authorities, etc). She also gained 10 years of experience in the medical device industry (wound dressings) in R&D, quality and consultancy. Additionally, Annick worked for about two years as SME in sterilisation at Allergan (pharmaceutical industry) in a site manufacturing terminally sterilised hormonal intrauterine devices.

As a SteriPro® director for two and a half years, Annick currently leads ethylene oxide sterilization projects in different Sterigenics plants and is supporting the plants as technical expert with pharmaceutical project responsibilities.

Dr. Andrew P. Bartko received a bachelor’s from the University of Pittsburgh in 1997 and a PhD in physical chemistry in 2002. His graduate work consisted of deciphering spatially heterogeneous relaxation dynamics of glass forming systems using novel rotational single molecule microscopy techniques. In 2002, Andrew joined the Softmatter Nanotechnology and Advanced Spectroscopy Team at Los Alamos National Laboratory where he studied the ultrafast photophysics of semiconducting quantum dots. Andrew is a senior scientist in Battelle’s technology development group, where he contributes to several applied spectroscopy efforts that focus on biological and chemical sensing. He now leads Battelle’s rapid, enumerated bioidentification system development program.

Ernie Jenness is a senior product manager for Mobius single-use products at MilliporeSigma. Ernie joined Millipore in 1990, holding positions in manufacturing, applications, R&D and product management. His focus for the last 15 years has been on single-use systems. Prior to Millipore, Ernie worked in the micro-electronics industry.

Ernie holds a bachelor’s in mechanical engineering and an MBA. He has published several articles related to single-use systems. He is a member of PDA, ISPE and BPSA.